Pregnant Women, Fetuses and Prisoners

Part of Human Subjects Protection for Clinical Research Staff: Vulnerable Populations and Undue Influence.

About 5 minutes. Free, in your language, no account needed.

Why this matters

Two groups get their own sections in the HHS regulations: pregnant women (with fetuses and certain neonates) and prisoners. Pregnancy adds a second interest, the fetus. Prison adds an environment that can make a free choice hard.

You may be the one who notices a participant is pregnant, or learns that a participant has been detained.

This lesson covers HHS rules under 45 CFR 46. They apply to research conducted or supported by HHS. Whether and how they reach a particular study is an institutional question, so ask your IRB office. State or other local rules may add requirements.

Pregnancy under Subpart B

Subpart B applies to research involving pregnant women, human fetuses, and neonates of uncertain viability or nonviable neonates, when the research is conducted or supported by HHS (45 CFR 46.201(a)). For these rules, pregnancy covers implantation until delivery. A woman is assumed to be pregnant if she shows a presumptive sign such as missed menses, until a pregnancy test is negative or until delivery (46.202(f)). So a participant who may be pregnant is treated as pregnant until the question is answered.

Pregnant women or fetuses may be involved only if listed conditions are met (46.204). Among them:

• Where scientifically appropriate, preclinical and clinical studies have been done, including studies in nonpregnant women.
• Risk to the fetus comes solely from interventions with a prospect of direct benefit to the woman or the fetus. Otherwise the risk is not greater than minimal and the research produces important biomedical knowledge that cannot be obtained another way.
• The woman consents when there is a prospect of direct benefit to her, or to both her and the fetus, or when the risk is minimal.
• The woman and the father consent when the prospect of direct benefit is solely to the fetus. The father's consent is not needed if he is unable to consent because of unavailability, incompetence or temporary incapacity, or if the pregnancy resulted from rape or incest.
• Those who consent are fully informed about the reasonably foreseeable impact on the fetus or neonate.

No inducements, monetary or otherwise, may be offered to terminate a pregnancy. People engaged in the research take no part in decisions about the timing, method or procedures of terminating a pregnancy, or in deciding the viability of a neonate (46.204(h) to (j)).

Prisoners under Subpart C

Subpart C applies to biomedical and behavioral research conducted or supported by HHS that involves prisoners (46.301(a)). Its stated concern is that incarceration may limit the ability to make a truly voluntary and uncoerced decision (46.302). A prisoner is anyone involuntarily confined or detained in a penal institution, including people detained pending arraignment, trial or sentencing (46.303(c)).

That is wider than "someone serving a sentence." If a participant is arrested mid-study, tell the investigator quickly so the team can ask the IRB what applies.

The IRB's makeup changes for this research. A majority of the Board, not counting prisoner members, must have no association with the prisons involved, and at least one member must be a prisoner or a prisoner representative (46.304).

The IRB also makes additional findings (46.305(a)). The research must fall in a permitted category. Any advantages offered must not be so large that they impair the ability to weigh risks in the limited-choice environment of a prison. The risks must be commensurate with those nonprisoner volunteers would accept. Selection must be fair and immune from arbitrary intervention by prison authorities or prisoners. Information must be in understandable language. The IRB needs assurance that parole boards will not consider participation, and there must be provisions for follow-up care.

In practice

A research nurse at an outpatient women's health site gets a call from a participant in a medication study. She missed her period and has not yet tested. The nurse does not wait for confirmation to take her seriously. She tells the investigator the same day, the participant is handled under the approved protocol's pregnancy provisions, and the call is documented.

What this looks like when it goes wrong

A participant in a long-term study is arrested and held pending trial. He misses a visit. A coordinator, wanting to keep the data complete, calls the facility and arranges a visit without telling anyone. Nobody checked with the IRB. A person held pending trial falls within the definition of prisoner, and the site has now continued research with someone in a setting where voluntariness is the whole concern. The site now has to bring what happened to the investigator and the IRB, who decide what comes next.

Key takeaways

• Subpart B covers pregnant women, fetuses and certain neonates in HHS-conducted or HHS-supported research. Pregnancy is assumed on a presumptive sign until a negative test or delivery.
• The woman's consent is enough in the minimal-risk or benefit-to-woman cases, and the father's consent is also needed when direct benefit is solely to the fetus, with the listed exceptions.
• No inducements to terminate a pregnancy are allowed, and research staff take no part in decisions about how or when.
• Subpart C exists because incarceration may limit voluntary choice. A prisoner includes people detained pending arraignment, trial or sentencing.
• The IRB's composition and findings change for prisoner research. Report a change in participant status to the investigator and let the IRB decide.